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510(k) K112453

STERISPINEPS PEDICLE SCREW by Safe Orthopaedics — Product Code NKB

K112453 is an FDA 510(k) premarket notification submitted by Safe Orthopaedics for the device "STERISPINEPS PEDICLE SCREW". The FDA issued a decision of Substantially Equivalent on November 15, 2011. The device falls under product code NKB (Thoracolumbosacral Pedicle Screw System), a Class II device regulated under 21 CFR 888.3070. Safe Orthopaedics has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 15, 2011
Date Received
August 25, 2011
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Thoracolumbosacral Pedicle Screw System
Device Class
Class II
Regulation Number
888.3070
Review Panel
OR
Submission Type

Intended to provide immobilization and stabilization of spinal segments in thoracic, lumbar, and sacral spine as an adjunct to fusion.

Other clearances by Safe Orthopaedics

  • K201648 — Sterispine™ PS (July 30, 2020)
  • K170528 — Sterispine™ PS (March 9, 2017)
  • K162531 — STERISPINE CC (December 29, 2016)
  • K151921 — STERISPINE PS (October 8, 2015)
  • K151747 — STERISPINE PS (October 5, 2015)
  • K151756 — STERISPINE LC CAGE (August 21, 2015)
  • K150092 — STERISPINE PS Pedicle Screw (February 10, 2015)
  • K140802 — STERISPINE PS (June 4, 2014)
  • K133893 — STERISPINE LC CAGE (March 14, 2014)
  • K130632 — STERISPINE PS PEDICLE SCREW (May 3, 2013)

Other clearances for product code NKB

  • K261284 — Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation Sy (July 14, 2026)
  • K253802 — KHEIRON® Spinal Fixation System, including patient specific K-ROD (July 1, 2026)
  • K253045 — “Socko” Vimax Spinal Fixation System (June 17, 2026)
  • K251251 — ChanPin Pedicle Screw Spinal System (June 9, 2026)
  • K260989 — Varion Thoracolumbar Fixation System (May 15, 2026)
  • K253739 — SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® (May 7, 2026)
  • K261130 — AccelFix Spinal Fixation System (May 5, 2026)
  • K253966 — PERLA® TL Posterior Thoraco-lumbar Fixation System (May 1, 2026)
  • K252542 — LEO Spinal System (April 29, 2026)
  • K253940 — M.U.S.T. Pedicle Screw System - Extension (April 28, 2026)

FDA data resources